study of an extended-release, crystalline formulation of recombinant human growth hormone (altu-238) in growth hormone deficient adults to determine pharmacokinetics, pharmacodynamics, and drug safety

Conditions: Adult Growth Hormone Deficiency

Summary: altu-238 is a long acting crystalline formulation of recombinant human growth hormone (rhgh) that is being developed for the treatment of growth hormone deficiency in adults and children. altu-238 is designed to require fewer injections than the currently available formulations of rhgh.


Eligibility criteria:
inclusion criteria: * growth hormone deficient men and women ages 18-60 years with a hypothalamic and/or pituitary structural lesion or longstanding idiopathic ghd * growth hormone deficiency as determined by pituitary testing within the last five years by either of the two following tests: 1. insulin hypoglycemia (glucose \< 50 mg/dl) with maximum gh \< 5 ng/ml (5 µg/l) by radioimmunoassay or \< 2.5 µg/l, if measured by immunoradiometric assay 2. arginine-ghrh infusions with maximum gh \< 5 ng/ml (5 µg/l) or \< 2.5 µg/l, if measured by immunoradiometric assay * women must be of non-child bearing potential (hysterectomy, tubal ligation, or iud are acceptable) during the three months prior to entering the study, or post-menopausal (no menses for one year or more), or six to twelve months without menses and β-estradiol levels \< 20 pg/ml * glucocorticoid use is allowed provided the subject has been on physiologic (\<7.5 mg prednisone or equivalent/day) replacement doses for at least 3 months * free thyroxine (t4) within the normal range at screening. if the subject is receiving thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks prior to screening * willing and able to provide written informed consent * bmi 20 - 36 kg/m2 exclusion criteria: * any previous or ongoing clinically significant illness that, in the opinion of the investigator, could prevent the subject from completing the study * any history of cancer within the past 5 years, except for dermal squamous and basal cell carcinoma with documented 6-month remission. subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission * bmi \ 36 kg/m2 * any allergic or abnormal reaction to human growth hormone * inability of the subject to discontinue use of their regularly prescribed human growth hormone treatment from six weeks prior to day -1 through the completion of the study * serum creatinine \> 1.4 mg/dl * hypocalcemia or hypercalcemia from any cause * hyperparathyroidism, osteomalacia or any other disorder which may affect bone and bone markers including the use of bisphosphonates or other medications for osteoporosis * participation in another clinical trial 30 days prior to screening * demonstrated inability to comply with protocol requirements (e.g. uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance, and/or poor likelihood of completing the study) * blood donation within 56 days of the screening visit * plasma donation within seven days of the screening visit * positive serum pregnancy test * women of child bearing potential * abuse of alcohol; to be determined by principal investigator * abuse of prescription or illicit drugs; to be determined by principal investigator